Search Results - "Roskos, Lorin"

A computational multiscale agent-based model for simulating spatio-temporal tumour immune response to PD1 and PDL1 inhibition by Gong, Chang, Milberg, Oleg, Wang, Bing, Vicini, Paolo, Narwal, Rajesh, Roskos, Lorin, Popel, Aleksander S.

“…When the immune system responds to tumour development, patterns of immune infiltrates emerge, highlighted by the expression of immune checkpoint-related…”
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Submicron Size Particles of a Murine Monoclonal Antibody Are More Immunogenic Than Soluble Oligomers or Micron Size Particles Upon Subcutaneous Administration in Mice by Kijanka, Grzegorz, Bee, Jared S, Korman, Samuel A, Wu, Yuling, Roskos, Lorin K, Schenerman, Mark A, Slütter, Bram, Jiskoot, Wim

“…Protein aggregates are one of the several risk factors for undesired immunogenicity of biopharmaceuticals. However, it remains unclear which features determine…”
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Population Pharmacokinetics of Palivizumab, a Humanized Anti-Respiratory Syncytial Virus Monoclonal Antibody, in Adults and Children by Robbie, Gabriel J, Zhao, Liang, Mondick, John, Losonsky, Genevieve, Roskos, Lorin K

“…OA  Errata ( vol. 56 , p. 5431 ) Classifications Services AAC Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg…”
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Population Pharmacokinetic Modeling of Benralizumab in Adult and Adolescent Patients with Asthma by Yan, Li, Wang, Bing, Chia, Yen Lin, Roskos, Lorin K.

“…Introduction Benralizumab, an interleukin-5 receptor alpha–directed cytolytic anti-eosinophil monoclonal antibody, was recently approved as add-on maintenance…”
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A novel approach to assess domain specificity of anti-drug antibodies to moxetumomab pasudotox, an immunotoxin with two functional domains by Vainshtein, Inna, Sun, Bo, Roskos, Lorin K., Liang, Meina

“…Biologics are potentially immunogenic and can elicit immune response. Complex biologics, such as bispecific antibodies or multi-domain molecules can induce…”
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A QSP Model for Predicting Clinical Responses to Monotherapy, Combination and Sequential Therapy Following CTLA-4, PD-1, and PD-L1 Checkpoint Blockade by Milberg, Oleg, Gong, Chang, Jafarnejad, Mohammad, Bartelink, Imke H., Wang, Bing, Vicini, Paolo, Narwal, Rajesh, Roskos, Lorin, Popel, Aleksander S.

“…Over the past decade, several immunotherapies have been approved for the treatment of melanoma. The most prominent of these are the immune checkpoint…”
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Population Pharmacokinetics and Exposure–Response Analysis for the Phase 3 COSMIC-311 Trial of Cabozantinib for Radioiodine-Refractory Differentiated Thyroid Cancer by Ly, Neang S., Li, Jing, Faggioni, Raffaella, Roskos, Lorin K., Brose, Marcia S.

“…Background and Objective In the USA, cabozantinib was approved for the treatment of patients aged ≥ 12 years with radioiodine-refractory differentiated thyroid…”
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Mechanistic modeling of a human IgG 4 monoclonal antibody (tralokinumab) Fab-arm exchange with endogenous IgG 4 in healthy volunteers by Wang, Bing, Goodman, Jo, Roskos, Lorin K

“…Therapeutic IgG antibodies engage in Fab-arm exchange with endogenous human immunoglobulin G4 (IgG ) to form monovalent hybrid molecules. A mechanistic…”
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Suppression of T Cell Activation and Collagen Accumulation by an Anti-IFNAR1 mAb, Anifrolumab, in Adult Patients with Systemic Sclerosis by Guo, Xiang, Higgs, Brandon W., Bay-Jensen, Anne C., Karsdal, Morten A., Yao, Yihong, Roskos, Lorin K., White, Wendy I.

“…Type I IFNs are implicated in the pathophysiology of systemic sclerosis (SSc). Recently, a Phase I open-label trial was conducted with an anti-IFNAR1 receptor…”
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Excessive outlier removal may result in cut points that are not suitable for immunogenicity assessments by Kubiak, Robert J., Zhang, Jianchun, Ren, Pin, Yang, Harry, Roskos, Lorin K.

“…Cut point determination is an important aspect of immunogenicity assay development. The cut point can be influenced by a myriad of factors. Key among those is…”
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A Computational Model of Neoadjuvant PD-1 Inhibition in Non-Small Cell Lung Cancer by Jafarnejad, Mohammad, Gong, Chang, Gabrielson, Edward, Bartelink, Imke H., Vicini, Paolo, Wang, Bing, Narwal, Rajesh, Roskos, Lorin, Popel, Aleksander S.

“…Immunotherapy and immune checkpoint blocking antibodies such as anti-PD-1 are approved and significantly improve the survival of advanced non-small cell lung…”
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Elimination mechanisms of therapeutic monoclonal antibodies by Tabrizi, Mohammad A., Tseng, Chih-Ming L., Roskos, Lorin K.

“…Understanding the factors that impact the pharmacokinetics of monoclonal antibodies is of high importance for effective therapy. Targeted therapies using…”
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Mechanistic modeling of a human IgG4 monoclonal antibody (tralokinumab) Fab‐arm exchange with endogenous IgG4 in healthy volunteers by Wang, Bing, Goodman, Jo, Roskos, Lorin K.

“…Therapeutic IgG4 antibodies engage in Fab‐arm exchange with endogenous human immunoglobulin G4 (IgG4) to form monovalent hybrid molecules. A mechanistic…”
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Immunogenicity assay cut point determination using nonparametric tolerance limit by Zhang, Jianchun, Li, Wenjia, Roskos, Lorin K., Yang, Harry

“…The newly released FDA guidance on immunogenicity assay development and validation recommends use of a lower confidence limit of the percentile of the negative…”
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From XenoMouse technology to panitumumab, the first fully human antibody product from transgenic mice by Jakobovits, Aya, Amado, Rafael G, Yang, Xiaodong, Roskos, Lorin, Schwab, Gisela

“…Therapeutic monoclonal antibodies have shown limited efficacy and safety owing to immunogenicity of mouse sequences in humans. Among the approaches developed…”
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Population Pharmacokinetics of Sifalimumab, an Investigational Anti-Interferon-α Monoclonal Antibody, in Systemic Lupus Erythematosus by Narwal, Rajesh, Roskos, Lorin K., Robbie, Gabriel J.

“…Background and Objectives Sifalimumab is a fully human immunoglobulin G1κ monoclonal antibody that binds to and neutralizes a majority of the subtypes of human…”
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A new method for identification of outliers in immunogenicity assay cut point data by Zhang, Jianchun, Arends, Rosalin HGP, Kubiak, Robert J, Roskos, Lorin K, Liang, Meina, Lee, Nancy, Chen, Cecil Chi-Keung, Yang, Harry

“…The cut point is an important parameter for immunogenicity assay validation and critical to immunogenicity assessment in clinical trials. FDA (2019) recommends…”
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Molecular Mechanism of HER2 Rapid Internalization and Redirected Trafficking Induced by Anti-HER2 Biparatopic Antibody by Cheng, Jackie, Liang, Meina, Carvalho, Miguel F., Tigue, Natalie, Faggioni, Raffaella, Roskos, Lorin K., Vainshtein, Inna

“…Amplification and overexpression of HER2 (human epidermal growth factor receptor 2), an ErbB2 receptor tyrosine kinase, have been implicated in human cancer…”
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Prevalence of IgG and Neutralizing Antibodies against Staphylococcus aureus Alpha-Toxin in Healthy Human Subjects and Diverse Patient Populations by Wu, Yuling, Liu, Xu, Akhgar, Ahmad, Li, Jia J, Mok, Hoyin, Sellman, Bret R, Yu, Li, Roskos, Lorin K, Esser, Mark T, Ruzin, Alexey

“…causes an array of serious infections resulting in high morbidity and mortality worldwide. This study evaluated naturally occurring serum anti-alpha-toxin…”
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Quantitative Measurement of the Target-Mediated Internalization Kinetics of Biopharmaceuticals by Vainshtein, Inna, Roskos, Lorin K., Cheng, Jackie, Sleeman, Matthew A., Wang, Bing, Liang, Meina

“…Purpose Measurement of internalization of biopharmaceuticals targeting cell surface proteins can greatly facilitate drug development. The objective of this…”
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